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December 9, 2020Pfizer COVID-19 Vaccine Receives Emergency Use Authorization
December 14, 2020
Emergency Use Authorization: Pfizer and BioNTech COVID-19 Vaccine
On Friday, December 11, 2020, the U.S. Food and Drug Administration (FDA) granted Pfizer and BioNTech an Emergency Use Authorization (EUA) for the companies’ jointly developed COVID-19 vaccine. The first doses of the vaccine shipped shortly after the EUA was issued, and vaccination efforts began on Monday, December 14, 2020.
BeneCard PBF has been closely following developments in new avenues of COVID-19 treatment and prevention. Here is what you need to know about the Pfizer/BioNTech vaccine.
While an EUA is not equivalent to full FDA approval of a product, it does allow the use of unapproved products in the detection, prevention, and/or treatment of a disease that represents a public health emergency when there are no approved options available. Authorization for the Pfizer/BioNTech vaccine is based on clinical studies in which it was both well-tolerated by patients and demonstrated 95% efficacy in preventing COVID-19 caused by the SARS-CoV-2 virus. The EUA allows for use of the vaccine to prevent COVID-19 in patients age 16 and up. 1
State and local healthcare agencies are currently in charge of vaccine distribution, guided by recommendations from the U.S. Centers for Disease Control and Prevention (CDC). Distribution and vaccination will occur in phases due to the limited availability of a COVID-19 vaccine. Individuals such as high-risk frontline healthcare workers and residents of long-term care facilities will receive the vaccine first. This initial phase is expected to vaccinate approximately 24 million Americans. Further vaccine distribution will continue to be rolled out in controlled phases, with early phases targeting other high-priority populations.
Vaccination of the general U.S. population is not expected to begin until spring of 2021 at the earliest. Eventually, U.S. residents are expected to be able to access the vaccine through retail pharmacies.
Ultimately, the timing of broad vaccine availability will be determined by how many vaccine candidates receive an EUA or FDA approval, and the manufacturers’ ability to supply the United States with their products. Moderna’s vaccine received EUA on December 18, 2020. Other vaccine candidates continue to be evaluated in clinical studies.
The cost of the vaccine will be paid for by the U.S. Government. However, the cost for administering the vaccine to covered members must be paid for by the Plan.
Early vaccination efforts will help to protect key medical personnel who are on the front line of fighting this disease. The current phased approach to vaccination is being conducted according to CDC guidelines, to help ensure those at greatest risk from COVID-19 are inoculated first.
- Wear a facemask that covers both nose and mouth whenever outside the household.
- Wash hands regularly for at least 20 seconds with soap and water.
- Use hand sanitizer that is at least 60% alcohol when washing with soap and water isn’t possible.
- Maintain a distance of at least six feet from others outside the household.
- Adhere to current federal, state, and local guidelines as they are updated in accordance with the changing COVID-19 landscape.
BeneCard PBF will continue to monitor ongoing developments in COVID-19 prevention, detection, and treatment, and will provide updates as we learn more.
Under the Affordable Care Act (ACA), applicable plan sponsors must cover the vaccine under either the medical or pharmacy benefit. Fees associated with COVID-19 vaccine administration are set by the U.S. Government and are anticipated to be $16.94 for the first dose and $28.39 for the second dose. Member copays will be zero per federal government regulations for plans that must comply with the Affordable Care Act. As previously stated, the U.S. Government has committed to paying for the cost of the vaccine.
For many medical plans, the vaccine administration fee will be part of the covered services already funded through the plan sponsors’ medical premiums.
For those plan sponsors currently using their pharmacy benefit to provide members access to ACA covered vaccines, BeneCard PBF is prepared to process COVID-19 vaccination claims under the prescription benefit plan. Our retail pharmacy network includes pharmacies that have contracted with the Department of Health and Human Services (HHS) and BeneCard PBF as COVID-19 vaccination providers and can bill medical and prescription benefits. This network includes well-known chains and independent pharmacies.
The COVID-19 vaccine is considered a preventive care benefit. Your plan has already defined how preventive care vaccines are covered. BeneCard PBF will process this vaccine according to the same rules already established by your plan.
We strongly encourage you to contact your medical benefit provider immediately to ensure processes are in place for the billing and administration of the COVID-19 vaccinations if you have selected to meet the preventative vaccines ACA requirements through your medical coverage.
If you would prefer to have COVID-19 vaccines handled differently than your current ACA covered vaccination process, please let your BeneCard PBF Account Executive know by January 4, 2021.
1 – "FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine." FDA News Release